The results from TONiC will be used to improve services by identifying aspects of MND that are important to people living with MND, but which might be underestimated by current service provision. As part of TONiC we will develop ‘outcome measures’ that can be used for future studies.
People with MND at any stage of their illness are welcome to participate, the “tick box” questionnaires are easily done at home at your own pace. If you cannot write, someone can tick your chosen response on your behalf. If you would like to take part you can contact the local TONiC champion at a centre near you – visit https://tonic.thewaltoncentre.nhs.uk, or you can contact the study team direct (0151 529 5668/2980) or e-mail firstname.lastname@example.org.
|Study title||Trajectories of Outcome in Neurological Conditions (TONiC)|
|UK Chief Investigator||Professor Carolyn Young|
|Research summary||Quality of Life (QoL) for people with disabling neurological conditions is affected by a range of factors, which have received considerable previous research attention. However, clinicians’ knowledge could be enhanced by two areas of additional enquiry.
1) Wide consultation:
a) Interviewing a range of people with the conditions (First stroke, traumatic brain injury, multiple sclerosis, neuromyelitis optica, spinal conditions, motor neurone disease), about factors influencing QoL;
b) Multi-disciplinary Panel- patients and clinicians- experienced in the conditions;
c) Draft Questionnaire assessed for relevance by people with the conditions.
Our earlier work suggested the importance of QoL factors like fatigue. We will utilise suitable previously-validated condition-specific QoL measures. It is possible that unvalidated or little-tested QoL factors will be suggested. If so, we will develop a new measure and test using
d) Focus Groups- patients’ and clinicians’ opinions on QoL factors, and priority factors for analysis.
Such analysis would have greater validity than that used previously as it would reflect a wide range of patient and clinician opinion.
2) Testing factors for QoL-influence:
e) Self-report Questionnaire data from a large Cross-Section of people with the conditions;
f) To assess QoL over time, questionnaire participants offered the choice to volunteer to complete the Questionnaire 6 months, 12 months, and 2 years later.
Data would be analysed using statistical techniques to determine the nature and strength of relations between different factors.
The researchers will develop and test models of factors affecting QoL and compare whether models vary between conditions.
The model structure reflects World Health Organisation impairment, activity, and participation areas. The benefit of this approach is that we are testing factors which reflect concerns of people experienced in the conditions, to develop a model which may assist interventions to improve Quality of Life.
|Inclusion/exclusion criteria||Inclusion criteria:
1. Diagnosed with one of the following diseases (first stroke, traumatic brain injury (TBI), multiple sclerosis (MS),neuromyelitis optica (NMO), spinal conditions or motor neurone disease (MND)). 2. Adults who are capable of answering questionnaires. 3. Capable of informed consent. 4. Have given informed consent. 5. For interviews, adults with the condition who are able to speak to a researcher, for any people with communication difficulties we will interview people with the assistance of a speech therapist or other support if necessary. For the questionnaire phase, we will not exclude people with difficulty writing due to their neurological condition and allow use of a scribe who records the answer chosen by the participant. 5. Participants wanting to do the qualitative work and cross sectional questionnaire stage can be at any time after diagnosis and participants wanting to do the longitudinal questionnaires commence within one year of diagnosis.
1. Not capable of informed consent 2. Have not given informed consent 3. Suffering from a concomitant serious medical or psychiatric condition
|Current status||Active – recruiting|
|Locations||Sites recruiting MND patients:
Basildon and Thurrock University Hospitals NHS Foundation Trust
Brighton & Sussex Uni Hospital
Cambridge University Hospitals NHS Trust
Cumbria Partnership NHSFT
Dartford and Gravesham NHS Trust
Hywel Dda University Health Board
King's College Hospital NHSFT
Royal Preston Hospital
LOROS hospice, Leicester
London North West University Healthcare NHS Trust
Norfolk and Norwich University Hospital
Northern Devon Healthcare Trust
John Radcliffe Hospital, Oxford
Peterborough City Hospital
Plymouth Hospitals NHS Trust
Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
Royal Devon and Exeter NHSFT
Royal Free Hospital
Royal Edinburgh Infirmary
Salford Royal Hospital
Royal Hallamshire Hospital, Sheffield
Royal Victoria Infirmary, Newcastle
The Queen Elizabeth Hospital Kings Lynn
The Walton Centre for Neurology and Neurosurgery
United Lincolnshire Hospitals
University Hospital of North Staffordshire
University Hospital Southampton NHSFT
West Suffolk NHSFT
York Teaching Hospital
|Contact details||Coordinating centre:
Telephone: 0151 529 5668 / 0151 529 2980 or email: email@example.com
|Recruitment group(s)||Patients with neurological conditions.|
|Recruitment target(s)||16,500 patients nationally.|
|Key dates||Recruitment start date (actual): 01 June 2012
Recruitment end date (target): 30 November 2019.
|Funder(s)||Motor Neurone Disease Association
|Sponsor||Walton Centre for Neurology & Neurosurgery NHS Foundation Trust|
|Study design||Longitudinal, Observational (questionnaire).|
|Intervention (if applicable)||Not applicable.|
|Phase (if applicable)||Not applicable.|
|Outcome measures||- To develop a biopsychosocial model of factors affecting quality of life (QoL) in different neurological conditions: multiple sclerosis (MS), motor neurone disease (MND), neuromuscular (NM) disorders, traumatic brain injury (TBI), spinal conditions, first stroke and neuromyelitis optica (NMO).
- To examine the validity of the model over time.
- To develop scales that measure different aspects of QoL in neurological illnesses, where generic scales are not available.
- To test the validity of some existing generic measures.
|Publications / Results reports||Links will be provided when papers from this study are published.|
|Participant Information Sheet|